The M.U.S.T. Fenestrated Pedicle Screw System when used without cement is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in conjunction with Meta+ Spine cement, the M.U.S.T. Fenestrated Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. M.U.S.T. Fenestrated Pedicle Screw System augmented with Meta+ Spine cement is intended for use at spinal levels where the structural integrity of the spine is not severely compromised.

· Meta+ Spine Cement

Meta+ Spine cement, when used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. The M.U.S.T. Fenestrated Pedicle Screw System, augmented with Meta+ Spine Cement, is for use at spinal levels where the structural integrity of the spine is not severely compromised.

Device Description

The purpose of this submission is to gain the clearance for the Meta+ Spine Cement to be used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, a Medacta M.U.S.T. Pedicle Screws System line extension including the following screws:

A. Poly-Axial Screws with standard screw head design, Ø 5, 6 mm (Dual Diameter) and 7mm (Single Diameter)
B. Poly-Axial Screws with large screw head design, Ø 7, 8, 9, 10 mm (Dual Diameter)
C. Mono-Axial Screws, Ø 5, 6, 7 mm (Dual Diameter)
D. Long Tab (LT) Poly-axial screws Ø 4.5. 5. 6. 7. 8 mm (Single Diameter).

The Meta+ Spine Cement as well as the M.U.S.T. Fenestrated Pedicle Screws are provided individually packed, sterile and single-use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System) and outlines the testing conducted to support its substantial equivalence to predicate devices.

However, the document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and performance data against predicate devices, rather than establishing specific, quantitative acceptance criteria and proving the device meets those criteria. The "Performance Data" section lists various non-clinical tests performed, but it does not specify quantitative acceptance criteria or report specific device performance results against those criteria in a table format.

Therefore, many of the requested details about acceptance criteria, test set specifics (sample size, provenance, expert adjudication, ground truth), and training set details for an AI/ML-based device cannot be extracted from this document. This submission is for a traditional medical device (bone cement and pedicle screws), not an AI/ML diagnostic or therapeutic device. As such, concepts like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," and "ground truth establishment for training" are not applicable to this type of submission.

Based on the information provided, here's what can be gathered:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the document as quantitative acceptance criteria with reported performance values in a table. The document states "testing activities were conducted to written protocols" and lists the types of tests. It asserts that "The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices with respect to the predicate devices." Implied acceptance is that the device performs equivalently to the predicate devices as per the listed tests.

Summary of Tests Performed (Implied Performance Goal: Substantial Equivalence to Predicate):

Test Category	Specific Tests Mentioned	Reported Device Performance (as stated in document)
PERFORMANCE TESTING	Mechanical properties rationale according to ASTM F1717-21	Supported substantial equivalence
	M.U.S.T. Fenestrated screws pull-out test according to ASTM F543-17	Supported substantial equivalence
	Geometrical analysis and comparison to prove fixation into the bone	Supported substantial equivalence
	Implant-implant & Implant-instrument interface rationale	Supported substantial equivalence
	Bone cement injection test on cadaver specimen and PU foam	Supported substantial equivalence (specifically, regarding different fenestration design and viscosity)
PYROGENICITY	Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (equiv. to USP <85>)	Supported substantial equivalence
	Pyrogen test according to USP chapter <151>	Supported substantial equivalence
BIOCOMPATIBILITY	Assessment	Supported substantial equivalence
SHELF-LIFE	Evaluation	Supported substantial equivalence

2. Sample sized used for the test set and the data provenance:

Sample Size: Not specified in the provided text. The document refers to "cadaver specimen and PU foam" for the bone cement injection test, but no specific number of specimens/tests is given for any of the listed tests.
Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective). This is unlikely to be relevant for non-clinical, in-vitro/ex-vivo biomechanical and material tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not specified. This document describes non-clinical performance testing of a physical medical device (bone cement and pedicle screws), not an AI/ML algorithm that requires expert annotation for ground truth. The "ground truth" for these tests would be derived from the physical properties and mechanical behavior measured against established ASTM standards and comparable predicate device data, not expert consensus on images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in studies involving human readers or AI output where subjective interpretation or consensus is needed (e.g., image reading). This is not relevant to the described biomechanical and material property tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC study is not mentioned, nor would it be relevant for this type of device. This device is a physical implant and bone cement, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This pertains to AI/ML algorithms. No such algorithm is part of this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the AI/ML sense. For the non-clinical tests performed, the "ground truth" is based on the physical and mechanical properties of the materials and devices as measured using validated test methods (e.g., ASTM standards) and compared against established performance benchmarks or predicate device specifications.

8. The sample size for the training set:

Not applicable. There is no AI/ML algorithm requiring a training set for this device submission.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set for an AI/ML algorithm is involved.

Summary

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June 12, 2024

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Medacta International S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 6386 Global Drive, Suite 101 Memphis. Tennessee 38141

Re: K241034

Trade/Device Name: Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: PML, NKB, KWQ Dated: April 16, 2024 Received: April 16, 2024

Dear Christopher Lussier:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Image /page/1/Picture/5 description: The image shows a digitally signed document. The signature is from Eileen Cadel, and the date of the signature is 2024.06.12. The time of the signature is 10:34:59 -04'00'.

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K241034

Device Name

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System

Indications for Use (Describe)

· M.U.S.T. Fenestrated Pedicle Screw

· Meta+ Spine Cement

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

er-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director, Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: April 16, 2024

II. Device

Device Proprietary Name:	Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
Common or Usual Name:	Bone Cement, Posterior Screw Augmentation
Classification Name:	Polymethylmethacrylate (PMMA) bone cement
Primary Product Code	PML
Additional Product Codes	NKB, KWQ
Regulation Numbers:	21 CFR 888.3027, 21 CFR 888.3070 , 888.3060
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following predicate devices.

Primary Predicate device:

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated ● Screw Systems, K160879, DePuy Spine, Inc.
Additional Predicate devices
M.U.S.T. Pedicle Screw Extension, K203482, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K171170, Medacta International SA
M.U.S.T. Pedicle Screw System, K141988, Medacta International SA
M.U.S.T. Pedicle Screw System, K132878, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K121115, Medacta International SA ●
F20, K103433, Teknimed SAS

IV. Device Description

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A. Poly-Axial Screws with standard screw head design, Ø 5, 6 mm (Dual Diameter) and 7mm (Single Diameter)
B. Poly-Axial Screws with large screw head design, Ø 7, 8, 9, 10 mm (Dual Diameter)
C. Mono-Axial Screws, Ø 5, 6, 7 mm (Dual Diameter)
D. Long Tab (LT) Poly-axial screws Ø 4.5. 5. 6. 7. 8 mm (Single Diameter).

The Meta+ Spine Cement as well as the M.U.S.T. Fenestrated Pedicle Screws are provided individually packed, sterile and single-use.

V. Indications for Use

M.U.S.T. Fenestrated Pedicle Screw System .
The M.U.S.T. Fenestrated Pedicle Screw System when used without cement is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

. Meta+ Spine Cement
Meta+ Spine cement, when used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. The M.U.S.T. Fenestrated Pedicle Screw System, augmented with Meta+ Spine Cement, is for use at spinal levels where the structural integrity of the spine is not severely compromised.

VI. Comparison of Technological Characteristics

M.U.S.T. Fenestrated Pedicle Screws .

The subject M.U.S.T. Fenestrated Pedicle Screws are substantially equivalent to the primary predicate, VIPER® Fenestrated Screw Systems (K160879), with regards to the following characteristics:

Diameters and lengths: O
Cannulation: O
Materials, except for the CoCrMo tulip and setscrew that are identical to Medacta predicate O (K203482, K171170, K141988, K132878 and K121115);
biocompatibility: O
device usage: O
sterilization; and O
packaging. O

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The subject M.U.S.T. Fenestrated Pedicle Screws differ from the primary predicate, VIPER® Fenestrated Screw Systems (K160879), with regards to the following characteristics:

threading profile: o
o shaft design:
polvaxiality: and O
fenestration. O

The partially different threading profile as well as the shaft design and polyaxiality have no impact on subject devices' safety and effectiveness since they do not affect the cement pathway and fenestration design. Additionally, both the threading profile and the polyaxiality of the subject screws are identical to the ones of Medacta predicate (K203482, K171170, K141988, K132878 and K121115).

The different fenestration design of the subject and predicate (K160879) screws does not raise new issues of safety and effectiveness as confirmed by bone cement injection test.

META+ Spine Cement .

The subject Meta+ is substantially equivalent to the primary predicate. CONFIDENCE™ High Viscosity Spinal Cement (K160879), with regards to the following characteristics:

PMMA general material; O
cement handling flow characteristics profile based on a powder and a liquid to be mixed; O
biocompatibility; O
device usage: and o
packaging. O

The different viscosity of the subject Meta+ with respect to the predicate cement (K160879) has no impact on device's safety and effectiveness as demonstrated by bone cement injection test. The different working time as well as the sterilization methods are strictly related to the specific cements' composition but they do not raise any new issue with regards to safety and effectiveness since these Meta+ features are identical to the ones of F20 cleared within (K103433). Meta+ is identical to already cleared F20 (K103433): it is the identical device rebranded by the manufacturer Teknimed for Medacta.

. Injection System

The subject and primary predicate (K160879) cement injection systems are substantially equivalent with regards to the following features:

same principle of use based on the presence of a mixing and an injection device; o
use of fluoroscopy to verify and monitor cement flow in order to prevent extravasation; O
removal procedure: O
O device usage; and
packaging. O

The different cement delivery system (controlled and measured thanks to a pressure control gun for the subject MedV+ vs. automatic based on a hydraulic pump for the predicate) is strictly linked to the related cement viscosity, but the safety and effectiveness is not affected as demonstrated by bone cement injection test.

Discussion

The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices with respect to the predicate devices.

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VII. Performance Data

Based on the risk analysis, testing activities were conducted to written protocols. The following validations and tests are provided in support of the substantial equivalence determination:

Non-Clinical Studies

. PERFORMANCE TESTING
- o Mechanical properties rationale according to ASTM F1717-21;
- o M.U.S.T. Fenestrated screws pull-out test according to ASTM F543-17;
- o Geometrical analysis and comparison to prove fixation into the bone;
- o Implant-implant & Implant-instrument interface rationale; and
- o Bone cement injection test on cadaver specimen and PU foam.
PYROGENICITY .
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia $2.6.14 (which is equivalent to USP chapter <85>)
- 0 Pyrogen test according to USP chapter <151> for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
BIOCOMPATIBILITY assessment ●
. SHELF-LIFE evaluation

Clinical Studies:

No clinical studies were conducted. ●

Conclusion VIII.

The information provided above supports that the subject devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”